Ward J R, Williams H J, Boyce E, Egger M J, Reading J C, Samuelson C O
Am J Med. 1983 Dec 30;75(6A):133-7. doi: 10.1016/0002-9343(83)90486-2.
A comparison of placebo, auranofin, and parenteral gold sodium thiomalate therapy in 209 patients with active rheumatoid arthritis was performed in a 21-week prospective, controlled, double-blind multicenter trial. When the 161 patients who completed at least 20 weeks of treatment were analyzed for different degrees of response, no remissions were identified. When 50 percent or greater improvement of pain/tenderness scores were compared for end of trial versus entry values, 9 percent of placebo-treated patients, 34 percent of auranofin-treated patients, and 48 percent of gold sodium thiomalate-treated patients showed important improvement that was statistically significant for both gold treatments. When 50 percent improvement for joint swelling was analyzed, 12 percent of the placebo-treated group, 28 percent in the auranofin-treated group, and 37 percent in the gold sodium thiomalate-treated group showed this degree of improvement. Auranofin almost achieved statistical significance for improvement in joint swelling when compared with placebo (p = 0.07), but gold sodium thiomalate was much better than placebo (p = 0.009). There was no statistically significant difference between the two gold treatments. Thus it appears that a subset of patients had an important response to gold therapy that would not be evident by the usual analyses of mean or median changes. Analysis for predictors of response did not discriminate between responders and nonresponders. Because the trial was limited to 21 weeks of therapy, no prediction of the longer-term-effects, especially for auranofin, should be inferred.
在一项为期21周的前瞻性、对照、双盲多中心试验中，对209例活动性类风湿性关节炎患者进行了安慰剂、金诺芬和肠胃外硫代苹果酸金钠治疗的比较。在对完成至少20周治疗的161例患者进行不同程度反应分析时，未发现缓解情况。当比较试验结束时与入组时疼痛/压痛评分改善50%或更高的情况时，9%接受安慰剂治疗的患者、34%接受金诺芬治疗的患者以及48%接受硫代苹果酸金钠治疗的患者显示出显著改善，两种金制剂治疗的改善情况均具有统计学意义。在分析关节肿胀改善50%的情况时，12%接受安慰剂治疗的组、28%接受金诺芬治疗的组以及37%接受硫代苹果酸金钠治疗的组达到了这一改善程度。与安慰剂相比，金诺芬在关节肿胀改善方面几乎达到统计学意义（p = 0.07），但硫代苹果酸金钠比安慰剂好得多（p = 0.009）。两种金制剂治疗之间无统计学显著差异。因此，似乎有一部分患者对金制剂治疗有显著反应，而这在通常的均值或中位数变化分析中并不明显。对反应预测因素的分析未能区分反应者和无反应者。由于该试验仅限于21周的治疗，不应推断对长期效果的预测，尤其是对金诺芬的预测。
